Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population. Cardio-Sis Study Group

The hypothesis that a therapeutic strategy aimed at lowering systolic blood pressure (SBP) below 130 mm Hg is superior to a conventional strategy targeted at below 140 mm Hg in hypertensive subjects has never been tested in randomized intervention studies. The Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica (Cardio-Sis) is a multi-centre study in non-diabetic, treated hypertensive subjects aged >55 years with uncontrolled SBP (>or=150 mm Hg) and at least one additional cardiovascular risk factor (ClinicalTrials.gov identifier: NCT00421863). Subjects are randomized to an SBP goal <140 mm Hg (conventional) or <130 mm Hg (aggressive), independently of baseline and achieved diastolic blood pressure (BP). Anti-hypertensive drugs dispensed for the study are restricted to a list of specific drugs. The primary outcome of the study is based on regression of left ventricular hypertrophy (LVH) using electrocardiography (ECG). The hypothesis is that subjects without LVH regression or with new development of LVH 2 years after randomization are 19% with conventional strategy and 12% with aggressive strategy. Secondary outcome is a composite pool of pre-specified fatal and non-fatal events. Randomization of 1111 subjects was completed by February 2007. Mean age of subjects (41% men) at entry was 67 years. BP was 158/87 mm Hg (systolic/diastolic) and prevalence of LVH by ECG was 21.0%. Cardio-Sis is the first randomized study specifically designed to compare two different SBP goals. Results will be broadly applicable to subjects with uncontrolled SBP under anti-hypertensive treatment

Glomerular filtration rate: A prognostic marker in atrial fibrillation-A subanalysis of the AntiThrombotic Agents Atrial Fibrillation.

OBJECTIVE An increased cardiovascular mortality and morbidity has been widely reported in patients with atrial fibrillation (AF). In this study, a subanalysis of the AntiThrombotic Agents Atrial Fibrillation (ATA-AF) is performed with the aim to evaluate estimated glomerular filtration rate (eGFR) as an independent prognostic marker of cardiovascular mortality and morbidity in patients with AF. METHODS AND RESULTS The ATA-AF study enrolled 7148 patients with AF, in 360 Italian centers. The eGFR was calculated from data reported in patient notes or hospital database. This post-hoc analysis included 1097 AF patients with eGFR data available and 1-year clinical follow-up. The endpoint was assessed as cardiovascular mortality and/or hospital admission for cardiovascular causes at follow-up. Patients were also divided in two groups according to the eGFR (<60 and ≥60 mL/min/1.73 m ). The Kaplan-Meyer curve for the mentioned endpoint showed a higher endpoint incidence in the group of patient with eGFR below 60 mL/min/1.73 m (P < 0.001). Using multivariate analysis (Cox regression), a trend toward a higher rate of occurrence of the primary endpoint was observed for eGFR below 60 mL/min/1.73 m without reaching the conventional level of statistical significance (hazard ratio [HR] 1.40; 95% confidence interval [CI] 0.99-1.99; P = 0.0572). When eGFR was included in the analysis as continuous variable a significant correlation was observed with the combined endpoint at the Cox regression (HR 0.99, 95% CI 0.98-0.99, P = 0.04). CONCLUSION The result of this post-hoc analysis indicates that an impaired eGFR is independently associated with worse prognosis among patients with AF